Recruiting

Observational Study

Sponsor:

Johns Hopkins Bloomberg School of Public Health

Code:

NCT06107933

Conditions

Infant Development

Breast Feeding

Environmental Exposure

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observational only

Study Details

Brief summary:

The goal of this observational study is to characterize and evaluate micro- and nano-plastic (MNP) exposures among mothers and infants in mother-infant dyads 1 or 3 months postpartum living in Baltimore, Maryland. The main questions it aims to answer are:

  • What MNPs are present in breastmilk and maternal blood samples and in their infants stool sample?
  • Are there associations between amount of maternal MNPs in breast milk and mass of MNP particles in infant stool?
  • Which environmental and lifestyle factors are most predictive of maternal MNP burden?
  • Is infant exposure to MNPs associated with birth weight and postnatal growth trajectories?

Participants will:

  • Complete several questionnaires assessing medical histories, lifestyle factors, environmental exposures, eating behaviors, etc.
  • Provide biological specimens including: maternal blood, stool, and breastmilk; infant stool
  • Clinical visit to have anthropometric measures documented including maternal height and weight, infant weight, length, and skin-fold thickness

Conditions

Infant Development

Breast Feeding

Environmental Exposure

Study ID

NCT06107933

Start date

Oct 1, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All gender expressions
  • Mothers at 1 or 3 months postpartum (± 2 weeks)
  • Intent to exclusively breastfeed for ≥ 6 months
  • Nulliparous and singleton births
  • Receiving only breast milk from the mother, with no formula supplementation

Exclusion Criteria:

  • Physical, mental, or cognitive disability that prevents participation; current incarceration
  • Chronic conditions in mother and/or infant (e.g., heart disease, cancer, autoimmune disease, diabetes, intestinal bowel syndrome/disease), conditions diagnosed for the first time during pregnancy (e.g. gestational diabetes), neurological conditions in mother and/or infant (e.g. epilepsy, seizures), psychological conditions in mother and/or infant (e.g. bipolar disorder), or neurological/psychological conditions diagnosed in mother during or immediately after pregnancy (e.g. postpartum depression)
  • Previously diagnosed with any major illness (e.g., intrauterine growth restriction, birth asphyxia, cancer) or eating disorder or previous gastric band surgery
  • Maternal antibiotic use during pregnancy or the postpartum period. Infant antibiotic use at any time during life or taking medications that could affect plastic exposure or the microbiome, such as medications administered via a plastic syringe.
  • Use of any breast pump except the Silicon Breast Pump for the 14 days prior to the clinical visit.
  • PHQ9 score greater than or equal to 10 indicating clinically relevant symptoms of moderate or worse depression
  • Infants who are intersex
  • Smoking, drug use (including marijuana use), or alcohol abuse

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

City Mother-Infant Pairs

Mother-infant pairs living in a Baltimore City, Maryland zip code exposed to micro and nano plastics.

County Mother-Infant Pairs

Mother-infant pairs living in a Baltimore County, Maryland zip code exposed to micro and nano plastics.

Interventions

Observational only

Exposure to micro and nano plastics

Primary outcome measure

  • Microplastic composition in maternal breastmilk [ Time Frame: 1 or 3 months +/- 2 weeks postpartum ]
  • Microplastic composition in maternal venous blood [ Time Frame: 1 or 3 months +/- 2 weeks postpartum ]
  • Microplastic composition in infant stool [ Time Frame: 1 or 3 months +/- 2 weeks postpartum ]
  • Infant weight [ Time Frame: 1 or 3 months +/- 2 weeks postpartum ]
  • Infant length [ Time Frame: 1 or 3 months +/- 2 weeks postpartum ]
  • Infant skinfold thickness [ Time Frame: 1 or 3 months +/- 2 weeks postpartum ]

Central Contacts and Locations

Central contacts

Tanya L Alderete, PhD

303-735-6249tanya.alderete@colorado.edu

Charlotte Haslett

7813256585chha5255@colorado.edu

Locations

East Baltimore Pediatric Inpatient and Outpatient Clinical Research Unit

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Rachel Salamone, RN

410-614-6365rsalamo3@jhu.edu

More Information

Sponsor

Johns Hopkins Bloomberg School of Public Health

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • microplastic
  • breastmilk
  • infant microplastic exposure
  • gut microbiome
  • fecal metabolome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health on 2026-06-09.